1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Effect of L-carnitine supplementation on resting metabolism rate and body composition in obese women, Double blinded control trial
Protocol summary
Summary
Obesity, a serious risk factor for chronic diseases, especially among women, is an important worldwide public health problem. The aim of this study was to evaluate the effects of L-carnitine supplementation on resting metabolism rate and body composition in obese women. In this clinical trial, 60 obese women with 10-15% weight reduction were randomly assigned to two groups (n=30 each) as follows: L-carnitine
supplementation (2g/day), 2: placebo corn starch tablets( placebo and L Carnitin by Karen pharmaceutical company). All interventions had a 4 week period and subjects along with weight loss diet (500cal daily calorie restriction). Body mass index, body fat percentage, and serum fasting free L-carnitine, resting metabolism rate and blood test for determination of triglyceride and thyroid hormone levels of each subjects were measured before and after interventions. Analysis of covariance was used for comparing of variables means between groups
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2014042417408N1 Registration date: 2016-04-25, 1395/02/06 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2016-04-25, 1395/02/06 Registrant information
Name
Sajad Salarkia
Name of organization / entity
Tehran University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 21 2631 1329 Email address
s-salarkia@razi.tums.ac.ir Recruitment status
Recruitment complete Funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date 2014-07-23, 1393/05/01
Expected recruitment end date 2014-10-22, 1393/07/30 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Effect of L-carnitine supplementation on resting
metabolism rate and body composition in obese women, Double blinded control trial
Public title
Effect of L-carnitine supplementation on resting
metabolism rate and body composition in obese women Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obese women (BMI 30-35) who succeed to lose 10 to 15% of body weight in last 3-6 months under the supervision of qualified dietitian and proper diet and also have clear diet records and the specified file Exclusion criteria: Patients (cardiac, pulmonary, diabetes and thyroid disease), smokers or people with
2 specific physiological conditions such as pregnancy,
lactation and menopause, People who are taking multivitamin supplements and athletes are excluded.
Age
From 18 years old to 45 years old Gender
Female Phase
3
Groups that have been masked No information
Sample size
Target sample size: 60
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Double blinded Blinding description Placebo
Used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 20, Hojat doost St, Keshavarz Blvd, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
City Tehran Postal code Approval date
2014-08-10, 1393/05/19
Ethics committee reference number 93/130/986/ص
Health conditions studied
1
Description of health condition studied Obesity
ICD-10 code E66.0
ICD-10 code description Obesity due to excess calories
Primary outcomes
1
Description BMI Timepoint
beginning and end of study (4 weeks) Method of measurement
weight persons with a scale and height with a gauge and then put the results in equation of BMI (weight/height x Height)
2
Description
Percent of body fat Timepoint
Beginning and end of study (4 weeks) Method of measurement
Body composition device
3
Description
Amount (kg) of body fat Timepoint
Beginning and end of study (4 weeks) Method of measurement
Weight persons with a scale and height with a gauge and then put the results in equation of BMI (weight/height x Height)
4
Description
Amount of lean body mass Timepoint
Beginning and end of study (4 weeks) Method of measurement
Body composition device
5
Description Waist to hip ratio Timepoint
Beginning and end of study (4 weeks) Method of measurement
Measure waist and hip size with a gauge and then use (waist/hip)
6
Description Weight Timepoint
Beginning and end of study (4 weeks) Method of measurement
Weight person with scale
3
Secondary outcomes
1
Description Lipid profile Timepoint
At the beginning and end of study Method of measurement
Blood test
2
Description
Resting metabolism rate Timepoint
At the beginning and end of study Method of measurement
Indirect calorimetry
Intervention groups
1
Description
Intervention group: L - carnitine, 1 gram tablets, 2 times per day for 4 weeks
Category
Treatment - Drugs
2
Description
Placebo group: Maltodextrin, 1-gram tablets, 2 times per day for 4 weeks
Category Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center Shariati Hospital
Full name of responsible person Sajad Salarkia
Street address
North Karegar Street, Shariati Hospital City
Tehran
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person Dr. Masoud Younesyan
Street address
No. 20, Hojat doost St, Keshavarz Blvd, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
City Tehran Grant name
93-01-161-25555-116552 Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source 100
Public or private sector empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Jalal Moludi Position
Ph.D of Nutrition
Other areas of specialty/work Street address
No. 20, Hojat doost St, Keshavarz Blvd, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.
City Tehran Postal code
982188974463 Phone
+98 21 8897 4463 Fax
+98 21 8897 4463 Email
jmoludi@yahoo.com Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Dr. Seyedali Keshavarz
4 Position
Phd
Other areas of specialty/work Street address
No. 20, Hojat doost St, Keshavarz Blvd, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.
City Tehran Postal code Phone
+98 21 8802 8281 Fax
+98 21 8897 4463 Email
S_akeshavarz@yahoo.com Web page address
..
Person responsible for updating data
Contact
Name of organization / entity Tehran University of Medical Sciences Full name of responsible person
Sajad Salarkia Position
MSc of Nutrition
Other areas of specialty/work Street address
No. 20, Hojat doost St, Keshavarz Blvd, School of
Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
City Tehran Postal code
582852850 Phone
+98 21 8897 4463 Fax
+98 21 8897 4463 Email
sajad.salarkia@gmail.com Web page address
.
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
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